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High Court Misinterprets Discoveries as Patent Ineligible

The Supreme Court has misinterpreted or chosen to ignore legislative history in finding
certain life sciences discoveries are patent ineligible, a law professor told a biotech
conference March 28.

Jeffrey A. Lefstin, associate academic dean and professor of law at the University
of California, Hastings College of the Law, said the court has tended to regard the
inclusion of discoveries along with inventions in the U.S. Constitution as excess
verbiage. But an examination of the legislative histories of the Patent Act and the
plant patent law shows Congress has regarded discoveries as patent eligible since
the beginning of U.S. patent law. “If you look at the history, it’s a different story
than the Supreme Court tells us,” Lefstin said.

He said the Supreme Court’s recent decision in
Mayo Collaborative Servs v. Prometheus Lab., Inc. finding a diagnostic method patent ineligible, and its denial of review in
Ariosa Diagnostics, Inc. v. Sequenom, Inc., where the U.S. Court of Appeals for the Federal Circuit found it was bound by
Mayo, “shows the court is done with this issue.” Noting the discussion the previous day
at the conference on a proposal to amend 35 U.S.C. §101, the patent eligibility section
of the patent law
, Lefstin said, “I do think it’s time for legislation that amends the patent law. It’s
the only way to go.”

The session was part of the BIO IP Counsels Committee Conference in Newport Beach,
Calif.

Legislative History

The language that a patent can be granted to one who “invents”
or “discovers” a composition, process or machine mirrors the “invention” and “discoveries”
language of the Constitution and also dates back to the 1790 Patent Act Section 1,
as well as to 19th century congressional revisions of the patent law, Lefstin said.

In 1930, Congress presented a clear example of congressional intent concerning discoveries
when it said in the Plant Patent Act that the law applies both to the acts of inventing
and discovery, Lefstin said.

The 1930 plant patent law said that in 1790, the term “inventor” had a dual meaning:
One who creates and one who finds out. “Congress tells us inventors can be discoverers.
The legislative history is quite clear,” he said.

A later plant patent lawsuit made congressional intent even clearer, Lefstin said.
Ex parte Foster (1951)
was about what could be protected as a plant mutant. The patent board found mere discovery
of a plant can’t qualify as an invention. “But Congress said, ‘Yes, it can,’ ” and
amended the plant statute in 1954 to clarify that seedlings found on cultivated land
are patent eligible. “Congress stated that this was clearly its intent in 1930 that
mutants, hybrids and seedlings discovered by persons engaged in agriculture should
be patent eligible,”
Lefstin said.

Congress also used the phrase “invention and discovery” in the Patent Act of 1952.
Lefstin said, “Under congressional standards, when language is carried forward the
original meaning applies.”

Lefstin also noted the definition of “process”
in Section 100B, which was added in the Patent Act of 1952, to be a process, art or
method that includes a new use of a known process, machine, manufacture, composition
of matter or material. He cited commentary by Pasquale Joseph Federico, former head
of the Patent Office and one of the movers of the 1952 legislation, that new uses
arise when a known substance or a thing is discovered to have some previously unknown
property. “This sounds like
Sequenom, which was a discovery that maternal blood or plasma could be used to test for fetal
abnormalities” that the Federal Circuit found to be patent ineligible, Lefstin said.

Acknowledge Law’s Protections

“Does it matter the Supreme Court has misinterpreted or ignored the legislative history?”
Lefstin asked. “From a practical standpoint, if you’re trying to convince Congress
to amend Section 101, it does matter. The patent system has traditionally protected
discoveries, so with that in mind, it could be argued there is no reason to change
the system. And it’s clear that the Supreme Court is entering into a time that it
is restricting patent eligibility from what it has been in the past, engaging in a
radical redefinition.”

Picking up on Lefstin’s statement that legislation may be the only alternative, Hans
Sauer, Biotechnology Innovation Organization’s deputy general counsel for intellectual
property, said even an amendment to the law wouldn’t necessarily change the Supreme
Court’s radical redefinition mindset. He elaborated on comments made the day before
by Kevin Noonan, a partner with McDonnell Boehnen, Hulbert &
Berghoff LLP and Bloomberg BNA advisory board member, that the amendment should openly
address the Supreme Court’s concerns about protecting medical research and physicians’
practice of law.

“We should say to the Supreme Court that it wasn’t that the court was wrong. We should
say there
is a protectionist role in Section 101, and this is what it is. And that is missing
from the proposals we’ve seen so far.”

To contact the reporter on this story: John T. Aquino in Washington at
jaquino@bna.com

To contact the editor responsible for this story:
Randy Kubetin at
RKubetin@bna.com

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